ATTACHMENT 1 QUALITY ASSURANCE SURVEIALLANCE PLAN.pdf

Quality Assurance Surveillance Plan (QASP)

The contractor will be evaluated in accordance with the following:

1. PURPOSE

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

• What will be monitored?

• How will monitoring will take place?

• Who will conduct the monitoring?

• How will monitoring efforts and results be documented?

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, The Government shall coordinate changes with the contractor through contract modification. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

2. GOVERNMENT ROLES AND RESPONSIBILITIES

The following personnel shall oversee and coordinate surveillance activities.

a. Contracting Officer (CO) – The CO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The CO shall also ensure that the contractor receives impartial, fair, and equitable treatment under this contract. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned CO: Rosetta Quinn, rosetta.quinn@va.gov, 813-893-1814

Organization or Agency: Networking Contracting Office 8

b. Contracting Officer’s Representative (COR) – The COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf.

Assigned COR: Primary: Ronald Algieri, Ronald.algieri@va.gov, 407-631-3065

Alternate: John Francisco, john.francisco@va.gov, 407-631-4048 mailto:rosetta.quinn@va.gov mailto:Ronald.algieri@va.gov mailto:john.francisco@va.gov

Organization or Agency: Orlando VA Medical Center

3. CONTRACTOR REPRESENTATIVES

The following employee(s) of the contractor serve as the contractor’s program manager(s) for this contract.

Primary Program Manager:

Alternate Program Manager:

4. PERFORMANCE STANDARDS

The contractor is responsible for performance of ALL terms and conditions of the contract. CORs will provide contract progress reports quarterly to the CO reflecting performance on this plan and all other aspects of the resultant contract. The performance standards outlined in this QASP shall be used to determine the level of contractor performance in the elements defined. Performance standards define desired services. The Government performs surveillance to determine the level of Contractor performance to these standards.

The Performance Requirements are listed below in Section 6. The Government shall use these standards to determine contractor performance and compare contractor performance to the standard and assign a rating. At the end of the performance period, these ratings will be used, in part, to establish the past performance of the contractor on the contract.

5. METHODS OF QA SURVEILLANCE

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

a. DIRECT OBSERVATION. 100% visual and audio surveillance of contractor’s provider(s) in the Operating Room (OR).

b. PERIODIC INSPECTION. Inspections scheduled and reported quarterly by COR appointment or as needed. All contractor’s provider(s) credentials, certifications, and required training courses will be reviewed by the COR to ensure they are current. All inspections and reports will be conducted in compliance with VA Privacy and Information security standards.

c. VALIDATED USER/CUSTOMER COMPLAINTS. Feedback via PATS (Patient Advocate Tracking System) and JPSR (Joint Patient Safety

Report) will be reviewed by the COR.

d. RANDOM SAMPLING. The COR will review Joint Patient Safety Report to ensure all incidents are reported timely. All reviews and reports will be conducted in compliance with VA Privacy and Information security standards.

e. VERIFICATION AND/OR DOCUMENTATION PROVIDED BY CONTRACTOR. The contractor must supply provider qualifications, pertinent provider documents including licenses, training compliance and invoices.

Quality Assurance Surveillance Plan (QASP)

Measures PWS Reference

Performance Requirement

Standard Acceptable Quality Level

Surveillance Method/

Frequency

Met AQL/DID NOT

MEET AQL-CPAR

RATING/ADD

COMMENTS

Provider Quality Performance

4.5.4.1. All Contractor’s

provider(s) must perform in accordance with clinical standards and as specified in the

PWS.

All (100%) of Contractor’s physician(s) must meet or exceed currently recognized national standards of the American Association for Neurological Surgeons (AANS). All (100%) of Contractor’s IONM Technologist(s) must meet or exceed currently recognized national standards of the American Board of Registration of Electroencephalographi c and Evoked Potential Technologists (ABRET).

All tracings are to be finalized and submitted within 48hrs unless that is outlined already elsewhere in the document.

100% Direct Observation Annually

Provider Quality Performance

4.5.4.2. All case tracings and

summaries for surgeries performed will be reviewed peer to peer or by Supervisor of vendor Neurologist before submission to OVAMC department of Surgery for FPPE and OPPE review.

All (100%) cases are to be reviewed

100% Periodic inspection of documents.

Weekly

Qualifications of Key Personnel

4.5.4.3 All Contractor’s

Neurophysiologist physicians(s) must be certified by the American Board of Neurological Surgery and hold a certificate of Fellowship in Intraoperative Neuromonitoring. All Contractor’s IONM technologist(s) must hold a Certificate (be certified) of Neurophysiologic Interoperative Monitoring (CNIM) from by the American Board of Registration of Electroencephalograph ic and Evoked Potential Technologists

(ABRET).

All (100%) Contractor’s physician(s) are Board Certified. All Contractor Physician(s) (100%) IONM certified.

Technologist(s) are ABRET certified.

100% Periodic inspection of qualification documents.

Scope of Practice /Privileging

4.5.4.4 Contractor’s

provider(s) perform within their individual scopes of practice/privileging.

All (100%) Contractor’s provider(s) perform within their scope of practice/privileges.

100% Contractor’s physician(s) perform within their scope of practice/privileges 100% of the time

Direct

Continuous

Patient Access 4.5.4.5 The Contractor must provide Contractor’s Neurophysiologist physician(s) and IONM technologist(s) in accordance with the operating hours and VA clinical schedule outlined in this PWS.

All (100%) Contractor’s Neurophysiologist physician(s) and IONM technologist(s) are on time and available to perform services.

Contractor’s Neurophysiologist physician(s) and

IONM

technologist(s) are on time and available to perform services 100% of the time.

Direct

Patient Safety 4.5.4.6 Patient safety incidents must be reported using VA Patient Safety Reporting System. All incidents reported immediately (within 24 hours.)

All (100%) patient safety incidents are reported using VA Patient Safety Reporting System within 24 hours of incident.

100% of patient safety incidents are reported using Patient Safety Report within 24 hours of incident.

No acceptable deviation.

Direct

Maintains licensing, registration, and certification

4.5.4.7 Updated Licensing, registration and certification must be provided as they are renewed. Licensing and registration information kept current.

All (100%) licensing, registration(s) and certification(s) for Contractor’s Neurophysiologist physician(s) and IONM technologist(s) must be provided as they are renewed. Licensing and registration information kept current.

100% licensing, registration(s) and certification(s) for contractor’s physician(s) shall be provided as they are renewed.

Licensing and registration information kept current.

Contractor’s provider(s) perform within their scope of practice/privileges 100%of the time.

No acceptable deviation.

Periodic Inspection Random Sampling

Mandatory Training

4.5.4.8 Contractor must

complete all required training on time per facility policy.

All (100%) of required training is completed on time by Contractor’s

100% Completions, no deviations

Periodic Sampling physician(s) and technologist(s).

Privacy, Confidentiality and

HIPAA

4.5.4.9 Contractor is aware of

all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA and complies with all standards Zero breaches of privacy or confidentiality.

All (100%) Contractor’s physician(s) and technologist(s) comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA.

100% Compliance Periodic Inspection, Contractor shall provide evidence of annual training required by the facility, reports violations per VA Handbook 6500.6.

1. CPARS RATINGS ASSIGNED TO QASP ITEMS:

Metrics and methods are designed to determine rating for a given standard and acceptable quality level. The following ratings shall be used (Reference: CPARS User Manual https://www.cpars.gov/cparsweb/assets/documents/CPARS_User_Manual.pdf)

EXCEPTIONAL: Performance meets contractual requirements and exceeds many to the Government’s benefit. The contractual performance of the element or sub-element being assessed was accomplished with few minor problems for which corrective actions taken by the contractor were highly effective.

Note: To justify an Exceptional rating, you should identify multiple significant events in each category and state how it was a benefit to the GOVERNMENT.

However, a singular event could be of such magnitude that it alone constitutes an Exceptional rating. Also, there should have been NO significant weaknesses identified.

VERY GOOD: Performance meets contractual requirements and exceeds some to the Government’s benefit. The contractual performance of the element or sub-element being assessed was accomplished with some minor problems for which corrective actions taken by the contractor were effective.

Note: To justify a Very Good rating, you should identify a significant event in each category and state how it was a benefit to the GOVERNMENT. Also, there should have been NO significant weaknesses identified.

SATISFACTORY: Performance meets contractual requirements. The contractual performance of the element or sub-element contains some minor problems for which corrective actions taken by the contractor appear or were satisfactory.

Note: To justify a Satisfactory rating, there should have been only minor problems, or major problems the contractor recovered from without impact to the contract.

Also, there should have been NO significant weaknesses identified.

MARGINAL: Performance does not meet some contractual requirements. The contractual performance of the element or sub-element being assessed reflects a serious problem for which the contractor has not yet identified corrective actions. The contractor’s proposed actions appear only marginally effective or were not fully implemented.

Note: To justify Marginal performance, you should identify a significant event in each category that the contractor had trouble overcoming and state how it impacted the GOVERNMENT. A Marginal rating should be supported by referencing the management tool that notified the contractor of the contractual deficiency (e.g.

Management, Quality, Safety or Environmental Deficiency Report or letter).

UNSATISFACTO

RY: Performance does not meet most contractual requirements and recovery is not likely in a timely manner. The contractual performance of the element or sub-element being assessed contains serious problem(s) for which the contractor’s corrective actions appear or were ineffective.

Note: To justify an Unsatisfactory rating, you should identify multiple significant events in each category that the contractor had trouble overcoming and state how it https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.cpars.gov%2Fcparsweb%2Fassets%2Fdocuments%2FCPARS_User_Manual.pdf&data=05%7C02%7C%7C1299a8a1556647c9c9b208dd897915ec%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C638817875334440754%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=6A9MQEEm9YUvO1cWqDUn1sC8wYUJvuCVqG%2F2AhW8s1E%3D&reserved=0 impacted the GOVERNMENT. However, a singular problem could be of such serious magnitude that it alone constitutes an unsatisfactory rating. An Unsatisfactory rating should be supported by referencing the management tools used to notify the contractor of the contractual deficiencies (e.g. Management, Quality, Safety or Environmental Deficiency Reports, or letters).

2. DOCUMENTING PERFORMANCE

a. The VA shall document positive and/or negative performance. Any report may become a part of the supporting documentation for any contractual action and preparing annual past performance using CONTRACTOR PERFORMANCE ASSESSMENT REPORTING SYSTEM (CPARS).

b. If contractor performance does not meet the Acceptable Quality level, the CO shall inform the contractor. This shall normally be in writing unless circumstances necessitate verbal communication. In any case the CO shall document the discussion and place it in the contract file. When the COR and the CO determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to CO. The CO shall in turn review and shall present to the contractor's program manager for corrective action.

The contractor shall acknowledge receipt of the CDR in writing. The CDR shall specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR shall also state how long after receipt the contractor has to present this corrective action plan to the CO. The VA shall review the contractor's corrective action plan to determine acceptability. The CO shall also assure that the contractor receives impartial, fair, and equitable treatment. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance and the acceptability of the Contractor’s corrective action plan.

Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO. See Sample on following page.

3. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

SIGNED:

COR NAME/TITLE DATE

SIGNED:

CONTRACTOR NAME/TITLE DATE

CONTRACT DISCREPANCY REPORT

1. CONTRACT NUMBER 2. REPORT NUMBER FOR THIS

DISCREPANCY

3. TO: (Contracting Officer) 4. FROM: (Name of COR)

5. DATES

a. CDR PREPARED

b. RETURNED BY

CONTRACTOR:

c. ACTION COMPLETE

6. DISCREPANCY OR PROBLEM (Describe in detail. Include reference to PWS Directive; attach continuation sheet if necessary.)

7. SIGNATURE OF COR Date:

8. SIGNATURE OF CONTRACTING OFFICER Date:

9a. TO (Contracting Officer) 9a. FROM (Contractor)

10. CONTRACTOR RESPONSE AS TO CAUSE, CORRECTIVE ACTION AND ACTIONS

TO PREVENT RECURRENCE. (Cite applicable quality control program procedures or new procedures. Attach continuation sheet(s) if necessary.)

11. SIGNATURE OF CONTRACTOR REPRESENTATIVE Date:

12. GOVERNMENT EVALUATION. (Acceptance, partial acceptance, reflection. Attach continuation sheet(s) if necessary.)

13. GOVERNMENT ACTIONS (Acceptance, partial acceptance, reflection. Attach continuation sheet(s) if necessary.)

14. CLOSE OUT

NAME TITLE SIGNATURE DATE

a.

CONTRACTOR

NOTIFIED

b. COR c.

CONTRACTING

OFFICER